An observational study in Peptic Ulcer Disease, HELICOBACTER PYLORI INFECTIONS and Helicobacter Pylori Infection, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Assiut University · Observational
This observational study aims to evaluate whether combining a simple blood test (H. pylori serology) with a non-invasive abdominal ultrasound can accurately predict severe complications in patients with peptic ulcer disease (PUD). Peptic ulcer complications, such as stomach bleeding or perforation, are serious and typically require an invasive procedure called an upper endoscopy for diagnosis and treatment.
Researchers want to find out if these two non-invasive tests can be used together to create a reliable risk-scoring system. This system would help doctors quickly identify which patients are at a high risk for complications and need an urgent endoscopy, compared to those who are at a lower risk and can be safely monitored without the invasive procedure.
The study will include adult patients presenting with stomach symptoms (like pain, nausea, or heartburn), as well as those with suspected or confirmed peptic ulcer disease. Participants will provide a blood sample to check for H. pylori antibodies and undergo a standard, painless abdominal ultrasound to examine the thickness of their stomach wall. An upper gastrointestinal endoscopy will be performed if it is clinically necessary as part of the patient's standard medical care.
Peptic ulcer disease (PUD) complications, such as bleeding, perforation, and obstruction, account for substantial hospital admissions and mortality. While upper gastrointestinal endoscopy remains the gold standard for diagnosing PUD, it is an invasive procedure that may not be readily available in resource-limited settings. H. pylori serology is a widely accessible non-invasive test, but its ability to predict ulcer severity or active complications remains unclear. Concurrently, abdominal ultrasound has emerged as a potential tool to evaluate gastric wall thickness and detect signs of perforation, yet data on combining it with serology is limited.
This prospective observational study aims to evaluate the diagnostic accuracy of combining H. pylori IgG serology with gastric ultrasound findings to predict peptic complications. The study will be conducted at AL-Rajhi University Hospital, Assiut University, Egypt.
All enrolled participants will undergo a standardized clinical assessment, including a detailed history of symptoms, NSAID use, and risk factors, alongside a physical examination. Upper gastrointestinal bleeding risk will be stratified using the Rockall and Glasgow-Blatchford scores.
Participants will undergo the following evaluations:
Laboratory Investigations: Quantitative measurement of H. pylori IgG antibodies via ELISA, complete blood count, coagulation profile, and inflammatory markers (CRP, ESR).
Gastric Ultrasound: High-resolution transabdominal ultrasound to systematically evaluate gastric wall thickness, wall stratification, and the presence of free fluid or pneumoperitoneum. Researchers will calculate a total ultrasound score (0-9 points) based on these parameters.
Endoscopic Evaluation: High-definition white light endoscopy performed within 24-48 hours of assessment (or emergently if indicated) to document ulcer size, location, and Forrest classification. This will serve as the diagnostic reference standard.
The study population consists of adult patients (aged 18 years and older) presenting to the Departments of Gastroenterology and Hepatology, Diagnostic Radiology, and General Surgery at AL-Rajhi University Hospital, Assiut University, Egypt. The population includes individuals presenting with dyspeptic symptoms (such as epigastric pain, nausea, vomiting, or heartburn), patients with suspected or confirmed peptic ulcer disease, and those presenting with acute complications like hematemesis, melena, or acute abdominal pain suggestive of perforation. Participants will be categorized into three groups: uncomplicated peptic ulcer disease, complicated peptic ulcer disease, and non-ulcer dyspepsia controls.
Exclusion Criteria:
Adult patients presenting with suspected or confirmed peptic ulcer disease without acute complications.
Adult patients presenting with acute complications of peptic ulcer disease, such as hematemesis, melena, or acute abdominal pain suggestive of perforation.
A control group consisting of adult patients presenting with dyspeptic symptoms but without peptic ulcer disease.
Diagnostic Accuracy of Combined H. pylori Serology and Gastric Ultrasound
The diagnostic accuracy (including sensitivity, specificity, positive predictive value, and negative predictive value) of combining H. pylori IgG serology and gastric ultrasound scores to predict peptic ulcer complications. These non-invasive findings will be compared against the reference standard of upper gastrointestinal endoscopy.
Time frame: Baseline (within 48 hours of initial assessment)
No study locations are listed for this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Assiut University